Ruminations by a non-academic general surgeon from the heart of the rust belt.

Saturday, March 14, 2009

The Little Man Fights the Power

From the WSJ is a story about Jonathan Leo, a professor of neuroanatomy at a small college in Tennessee, who had the outrageous gall to criticize the conclusions of a paper published in JAMA last spring (how dare he!) regarding the efficacy of the anti-depressant Lexapro in treating post-stroke depression.

Dr Leo wrote an on-line piece for the British Medical Journal (worth a read) in which he points out that behavioral therapy was just as efficacious as Lexapro when compared to placebo but that this was downplayed in the original article leading many in the mainstream media to conclude that SSRI's ought to be routinely prescribed for post-stroke patients. A follow-up letter to the editor last year from Dr. Leo resulted in an acknowledgement in JAMA of his point but by that time, the story had run its course and received little notice outside the esoteric circles of psychiatry.

So Dr. Leo proceeded to write this piece in BMJ where he also highlights past financial ties between the lead author of the Lexapro paper and Forest Laboratories (coincidentally, the maker of Lexapro) which was not noted in the publication last spring. JAMA recently printed an apology letter from the lead author citing "errors of memory" as the reason for the initial lack of transparency.

Now I'm a sucker for stories of the little man fighting the power. I love this kind of thing. Miracle on Ice. Georgetown vs. Villanova. Ohio State vs. Miami in the 2003 title game. David vs. Goliath. And now Jonathan Leo vs. the JAMA ivory tower. Here's JAMA editor-in-chief Catherine DeAngelis on Leo:

“This guy is a nobody and a nothing” she said of Leo. “He is trying to make a name for himself. Please call me about something important.” She added that Leo “should be spending time with his students instead of doing this.”

Leo also received a phone call from JAMA executive deputy editor Phil Fontanarosa (I'm sure he's the kind of dude who probably introduces himself at conferences as 'Hi, I'm Executive Deputy Editor Phil Fontanarosa, how about getting me another coffee, hey?') who allegedly had this exchange on the phone with Leo:

“He said, ‘Who do you think you are,’ ” says Leo. “He then said, ‘You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry.”

Well, isn't that nice. The lesson, as always: don't question what the smart guys at large academic centers are doing. Conflicts of interest and manipulations of data will be handled behind closed doors, don't you worry. We'll take care of everything, they say.

The insidious aspect of this is, as we move into an inevitable era of comparative effectiveness research (CER) as a way to control costs and streamline clinical decision making, it's papers like this with all their hard data and pure science (ostensibly) which will serve as the foundation of those very algorithmic decision trees that physicians will be expected to follow (lest they be labeled a 'bad doctor'). Good for Dr Leo at tiny Lincoln Memorial University. Corruption and financial incentives are not just temptations of our representatives in Washington DC....

Catherine DeAngelis and Phil (whatever is last name is) sound like a couple of horrible people. You know what's sad, is these type people spend their whole entire lives putting down others to the point that they never realize they are the scum of the earth.

This week Fox News had a story about a Dr Muney (sp?) in New York who offers a flat rate monthly fee of 79.00 and has a private contract with each patient to cover office visits. He has been assaulted by the insurance cartel in NY and accused of being an insurance company. The state board is investigating....Fee for service and concierge medicine is seen a a 'real threat' to insurance companies. Insurance companies and employers previously have wanted to have all the control of health care dollars. Employers jumped on the bandwagon to attract employees with benfits.

We should all support concierge medicine, because it will be a very powerful tool. We may even be able to 'give away' treatment and care with this idea. The JAMA should jump on this approach. It is certainly a good option, and an elective one at that, no one is being forced to take this approach.

"The lesson, as always: don't question what the smart guys at large academic centers are doing."

Really? That's the lesson? I know what your saying from a visceral level, however, the truth is that there are bad apples in every game. I get your point, but I think that having a system of checks and balances through peer-reviewed publication is the only way to achieve intellectual integrity. This is much more possible than the pseudo-science and "art" of "this is how I do it and I know its good" era of medicine. How can you tell me that outside of a structured system that you can have more integrity and less conflicts of interest?

"Conflicts of interest and manipulations of data will be handled behind closed doors"... This kind of behavior needs to be punished severely.

"The insidious aspect of this is... comparative effectiveness research (CER) as a way to control costs and streamline clinical decision making, it's papers like this with all their hard data and pure science (ostensibly) which will serve as the foundation of those very algorithmic decision trees that physicians will be expected to follow (lest they be labeled a 'bad doctor')."

Now with this it appears to me that you have painted a very broad stroke of damnation for medical research as a means to identify best practices. I may be misinterpreting your fervent style. I support evidence based medical practice or CER or whatever its called based on my belief that with structure comes understanding. It not only helps us do what is best, but it helps us identify when what we are doing is not optimal. As a surgeon, I was brought up with the book "Surgical Decision Making" as a way of helping think of how to approach the myriad of problems that we face. This book is an algorithmic logical approach to safe practices in surgery, and was ahead of its time (before EBM and CER). I think that these strategies are making physicians upset because of the real potential that they will be mis-used by administrators looking always at the bottom line dollar and ignore the intracacies of medical practice. Since I am a real-working surgeon, I can share this concern. But I do so with the honest belief that I am going to help my patients more if I pay attention to practicing medicine based on the best available evidence.

You're missing the point. The same theme is happening writ large with ECASS III, with bias and funding prompting a decreased emphasis on the ATLANTIS trial which purported harm for tPA, and a huge push to give tPA out to 4 hours with one study.

Or, the idea that we should always collect blood cultures in pneumonia patients because a study showed a decrease in mortality with no proof that cultures ever changed therapy.

These studies are the way to answer questions, yes, but only when done in a transparent way and with multiple studies. This example is not the first time we've been unable to trust the honesty of authors. And it begs the question what might be found if all articles were examined with as much scrutiny.

EBM is not conducted currently in the attitude of open scientific exploration. It is a parlor game, often, to get a new drug accepted by the government, and packaged into a guideline. Witness also the Xigris inclusion in the Sepsis campaign despite it's increase in bleeding risk.

On, and on. As one raised on EBM, I see as many flaws as I do fulfilled promises.

Sucher- I have no problem with CER and evidence based decision making (see my post on breast cancer and MRI). But just because a study comes from one of the ivory towers, it would be prudent not to assume it has been necessarily vetted properly to make sure there are no conflicts of interest. We need our RCT's and evidence based algorithms to be irreproachable, now more then ever. A story of JAMA trying to intimidate a whistleblower or hide author ties to a pharm company is not a minor thing. If we can't trust JAMA and JACS and Archives and all the rest, then CER is just a pipedream...

I personally think (and have noted here on your blog) that the whole peer-review process is suboptimal. We need to have faith that the articles in the publications actually have conclusions that are supported by the evidence. We need to know that the study was conducted correctly and that if there are any concerns, then they are at least vetted in the open.

I think that it is too darn hard for even the above average physician to critically read a research study paper. You honestly have to do it often, and with a good background in statistics and study design. And so my point is, this should be done by the reviewers and editors of the publication better than it is today.

I really appreciate the time you put into this blog. It is compelling and honest. Thank you.

Can you take any journal seriously thats filled with ads for various expensive Pharmaceuticals??? Now I haven't looked at a JAMA this Millenium, but I'd be surprised if there's not several SSRI spreads...and not the cheap generic ones...

Yes you can take journals seriously. I think one way to disrupt the whole business is to get Google to get all this stuff online so that we all have access to it. I mean, if you can get satellite data and maps on the Internet for all to see, why not get medical knowledge out to the masses? Its amazing that this isn't the case. If you look back at the history of computing, Dr. Ledley in his 1959 article had discussed the need for a computer network that would share medical knowledge. 1959! Clearly the publishers wouldn't want this... losing a big business.

I'm not the brightest bulb, but I don't think I'm stupid either; and I have a tough time critically assessing most articles most of the time. That is because there are not very many groundbreaking papers out there, i.e. the ones that actually effect a meaningful change in how we do business. The point is if physicians have a tough time with the literature, what do you expect from the lay public? The lay people I've met who read medical literature (JAMA, NEJM, etc) are mostly nutty, including a family member of mine. I don't think it does anyone any good for the lay public to read the medical literature. No more than it would do anyone any good if I started reading the primary mechanical engineering or physical chemistry or eastern mongolian literary history journals. I'm not saying those subjects are uninteresting, but without any background those journals are destined to mean less than nothing to me. There is a reason we have slowly climbed successive building blocks to get to where we are: they are necessary.

I goofed. By masses I meant all physicians and other healthcare professionals.

As it stands now, most of this information is locked up in large medical groups and academic centers because the majority of doctors in solo or small group practices don't have the money to spend on having access to all the journals. So, for instance... maybe you get JACS. OK, you read an artical in JACS. Now you're actually interested in the article, but without unfettered access to the rest of the literature, you're stuck with this one article and what you already know. That doesn't get you very far. I am fortunate in that when I read something that is interesting, AND I don't know much about the topic, I am able to follow the reference trail and get the details and history of what the whole topic is really about.

Now what about the physicians throughout the rest of the world. A great number of medical professionals in other countries have very little in terms of access to the literature. My partners go over to Germany every year to give multiple talks on various surgical topics. The physicians over there (coming from many different countries throughout the continent) are starving for the knowledge that we have. They absolutely need to have access to this information.

What I have proposed is that someone with the power and money needs to introduce a disruptive model that will allow all of us to gain access to all the medical and scientific journals for free. (nothing is really free). I am convinced that there must be a business model that could do this and allow for the journals to maintain profitability. Google? Are you out there?

A little off topic, but maybe not I am the dad of a autistic child I called the AAP journal when I found out that verstraeten work was changed 4 or 5 times to no link, I asked the woman that answered the phone, how could they put his work in their journal in his name when he has been working at GSK for three and a half years and not the CDC. Also they were in thimerosal litigation at that time? I asked is that not a conflict of interest? then I said what if anything would be a conflict of interest at your journal? She said that's a very good question sir I will have someone contact you. At that time I was thinking, I would get verstraitens work removed like they removed Dr.Wakefield for his perceived conflict. What happened next was from the twilight zone. The phone rang, when I looked at the phone it said unknown name unknown number. I answered it, the man said I am the top Doc. of this journal and I am telling you If you call us back if you bother us again on this issue there will be a knock at your door, and you know what that means!. I was stunned and speechless then I thought you just threatened me! So I asked what did you just say to me? and he said you heard me, and he hung up. Man I was bewildered, why did he even call me? I was thinking, When he did not have to. It remained a mystery until I was reading an email from the CDC and a woman was saying we have searched frantically and can't find anything to support us and the IOM meeting is in weeks we will have to go over seas to get us a study and they did. They went to Denmark we all know that fraud. And later I was reading I think it was Dr.Cochi from the CDC he was in a Email practically begging them to put the Denmark study in pediatrics. So it dawned on me this guy was probibility angry that called me, because the CDC was wanting to put another fraudulent study in his journal so that day he took it out on me. I the dad of a very severely vaccine damaged child, all I was doing that day was asking a legitimate question. Now as far as the Denmark study being a good study I will let someone more qualified answer that question than me Dr. Irva Hertz-Picciotto "As questionable as the US thimerosal study was, "it was an improvement on other studies, including the two in Denmark, both of which had serious weaknesses in their designs," Dr. Irva Hertz-Picciotto, Professor of Public Health at UC Davis Medical School and Chair of the NIEHS panel, told reporter Dan Olmsted at UPI.That leaves very little for the CDC to go on in terms of proving that thimerosal and autism are not associated in any way" So this is not the only time someone misused their power that is in charge of a Journal. And now when someone says to me is that peer reviewed and in a prestigious Journal I laugh, and say would a prestigious journal call you up and threaten you for asking a legitimate question.

"How dare you question the 'integrity' of this office?' Why you were just a mere gleam in your father's eye when I wrote theee boook on this subject....we would still be in the dark ages with that kind of thought dominating our 'progress' in any field..... Pompous,, self righteous jackasses!!!

Joseph - just a suggestion. A lot of medical schools, major universities and even hospitals have public libraries that are open during business hours, and they usually have access to a lot of these journals if you're so inclined.

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